The Food and Drug Administration (FDA) has granted Orphan Drug designation to TNP-2092 (TenNor Therapeutics) powder for intravenous (IV) injection for the treatment of prosthetic joint infections.

Prosthetic joint infection is a complication of hip or knee arthroplasties that often requires a prolonged course of antimicrobials and surgical intervention due to the formation of bacterial biofilms. TNP-2092 is a first-in-class multitargeting drug conjugate that specifically inhibits 3 essential targets in bacterial biofilms: RNA polymerase, DNA gyrase and topoisomerase IV.

The designation was based on data from in vitro and in vivo models that showed TNP-2092 had potent bactericidal activity against major pathogens associated with bacterial biofilms, a low potential for developmental resistance and an excellent safety profile. The efficacy of TNP-2092 was also found to be superior to the current standard of care against bacterial biofilms in animal models. 

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In addition, the Company has reported positive topline data from the phase 2 trial (P2_ABSSI) of TNP-2092 IV for the treatment of acute bacterial skin and skin structure infection. An oral formulation of TNP-2092 is also currently being investigated for the treatment of diseases associated with gastrointestinal infections.

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